Long-term Immunogenicity Study of Herpes Zoster Subunit Vaccine (GSK1437173A) and Immunogenicity and Safety Assessment of Revaccination With Two Additional Doses in Adults With Renal Transplant From Study ZOSTER-041

212340

The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination course from study ZOSTER-041 (NCT02058589). This study also assessed immune responses as well as safety after revaccination with 2 additional doses of the HZ/su administered at 6 to 8 years after the 2-dose primary vaccination course.

2019-12-09

2022-08-12

2024-08-14

Active (not recruiting)

Early phase I

68

Inclusion Criteria: * Inclusion criteria for enrolment * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure. * Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course. * Inclusion criteria for revaccination * Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination. * Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit. * Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female subjects of childbearing potential may be revaccinated, if the subject: * has practiced adequate contraception for 30 days prior to revaccination, and * has a negative pregnancy test on the day of revaccination, and * has agreed to continue adequate contraception up to 2 months after completion of the revaccination series. Exclusion Criteria: Exclusion criteria for enrolment Medical conditions * Vaccination against HZ since completion of study ZOSTER-041. * Significant underlying illness that, in the opinion of the investigator, is expected to prevent completion of the study. * Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study. Prior/Concurrent clinical study experience • Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study. Exclusion criteria for revaccination Medical conditions * History of confirmed HZ within one year before revaccination visit (Visit 3). * More than one organ transplanted. * Any additional confirmed or suspected immunosuppressive or immunodeficient condition. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study or make vaccination unsafe. Prior/Concomitant therapy * Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26). * Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months of first revaccination dose of study vaccine. * Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of maintenance immunosuppressive therapies. * Planned administration/administration of a live vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. * Planned administration/administration of a non-replicating or subunit vaccine, not foreseen by the study protocol, in the period starting 8 days before and ending 30 days after each dose of study vaccine. Other exclusion criteria for revaccination * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions up to 2 months post-revaccination Dose 2. * Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}

2023-12-20